Trial Outcomes & Findings for Modulated Light Therapy in Participants With Pattern Hair Loss (NCT NCT04019795)
NCT ID: NCT04019795
Last Updated: 2024-09-05
Results Overview
The primary efficacy outcome of this study is mean change in hair count from baseline. Standardized Canfield macro-photographs will be taken to capture digital images at baseline and will be compared to images captured at various endpoints throughout the study. Multiple images will be taken at each endpoint and will be reviewed by independent blinded observers to conduct the hair count
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
160 participants
Primary outcome timeframe
Primary efficacy endpoint is 16-weeks follow-up from the initial application at baseline
Results posted on
2024-09-05
Participant Flow
Participant milestones
| Measure |
Non-Active REVIAN (Sham) Cap 100
Sham (Control) Group
REVIAN 100: The REVIAN System includes a Cap configured for portable use with rechargeable battery and adapter with active LEDs using modulated light therapy (MLT trademark). Daily 10-minute treatments are done in the home over the course of 26 weeks. Intervention adherence will be assessed via firmware in the Cap and monitored by the clinical sites.
REVIAN 100 contains LEDs that are not powered for light therapy
|
Active REVIAN Cap 101
(625 nm and 660 nm)
REVIAN 101: The REVIAN System includes a Cap configured for portable use with rechargeable battery and adapter with active LEDs using modulated light therapy (MLT trademark). Daily 10-minute treatments are done in the home over the course of 26 weeks. Intervention adherence will be assessed via firmware in the Cap and monitored by the clinical sites.
REVIAN 101 delivers 625 nm and 660 nm wavelengths of red light.
|
Active REVIAN Cap 102
(425 nm)
REVIAN 102: The REVIAN System includes a Cap configured for portable use with rechargeable battery and adapter with active LEDs using modulated light therapy (MLT trademark). Daily 10-minute treatments are done in the home over the course of 26 weeks. Intervention adherence will be assessed via firmware in the Cap and monitored by the clinical sites.
REVIAN 102 delivers 425 nm wavelengths of red light.
|
Active REVIAN 103
(425 nm, 625 nm and 660 nm)
REVIAN 103: The REVIAN System includes a Cap configured for portable use with rechargeable battery and adapter with active LEDs using modulated light therapy (MLT trademark). Daily 10-minute treatments are done in the home over the course of 26 weeks. Intervention adherence will be assessed via firmware in the Cap and monitored by the clinical sites.REVIAN 103 delivers 425 nm + 625 nm and 660 nm wavelengths of red light.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
42
|
39
|
41
|
38
|
|
Overall Study
COMPLETED
|
37
|
35
|
35
|
35
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
6
|
3
|
Reasons for withdrawal
| Measure |
Non-Active REVIAN (Sham) Cap 100
Sham (Control) Group
REVIAN 100: The REVIAN System includes a Cap configured for portable use with rechargeable battery and adapter with active LEDs using modulated light therapy (MLT trademark). Daily 10-minute treatments are done in the home over the course of 26 weeks. Intervention adherence will be assessed via firmware in the Cap and monitored by the clinical sites.
REVIAN 100 contains LEDs that are not powered for light therapy
|
Active REVIAN Cap 101
(625 nm and 660 nm)
REVIAN 101: The REVIAN System includes a Cap configured for portable use with rechargeable battery and adapter with active LEDs using modulated light therapy (MLT trademark). Daily 10-minute treatments are done in the home over the course of 26 weeks. Intervention adherence will be assessed via firmware in the Cap and monitored by the clinical sites.
REVIAN 101 delivers 625 nm and 660 nm wavelengths of red light.
|
Active REVIAN Cap 102
(425 nm)
REVIAN 102: The REVIAN System includes a Cap configured for portable use with rechargeable battery and adapter with active LEDs using modulated light therapy (MLT trademark). Daily 10-minute treatments are done in the home over the course of 26 weeks. Intervention adherence will be assessed via firmware in the Cap and monitored by the clinical sites.
REVIAN 102 delivers 425 nm wavelengths of red light.
|
Active REVIAN 103
(425 nm, 625 nm and 660 nm)
REVIAN 103: The REVIAN System includes a Cap configured for portable use with rechargeable battery and adapter with active LEDs using modulated light therapy (MLT trademark). Daily 10-minute treatments are done in the home over the course of 26 weeks. Intervention adherence will be assessed via firmware in the Cap and monitored by the clinical sites.REVIAN 103 delivers 425 nm + 625 nm and 660 nm wavelengths of red light.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
1
|
2
|
|
Overall Study
Treatment non-compliance
|
3
|
1
|
2
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Male participants were analyzed using this scale. Categories are not mutually exclusive. Note: The Norwood scale was used to classify one female subject. Female subject VCR-101, assigned to the Active REVIAN Cap 101 group, has result in Norwood-Hamilton Hair Loss Scale as 'IIa'. Therefore, the Active REVIAN Cap 101 group has a total of 31 (instead of 30) and the total baseline participants 121 (instead of 120).
Baseline characteristics by cohort
| Measure |
Non-Active REVIAN (Sham) Cap 100
n=42 Participants
Sham (Control) Group
REVIAN 100: The REVIAN System includes a Cap configured for portable use with rechargeable battery and adapter with active LEDs using modulated light therapy (MLT trademark). Daily 10-minute treatments are done in the home over the course of 26 weeks. Intervention adherence will be assessed via firmware in the Cap and monitored by the clinical sites.
REVIAN 100 contains LEDs that are not powered for light therapy
|
Active REVIAN Cap 101
n=39 Participants
(1.67mW/cm2 of 625 nm and 660 nm)
REVIAN 101: The REVIAN System includes a Cap configured for portable use with rechargeable battery and adapter with active LEDs using modulated light therapy (MLT trademark). Daily 10-minute treatments are done in the home over the course of 26 weeks. Intervention adherence will be assessed via firmware in the Cap and monitored by the clinical sites.
REVIAN 101 delivers 625 nm and 660 nm wavelengths of red light.
|
Active REVIAN Cap 102
n=41 Participants
(1.67mW/cm2 of 625 of 425 nm)
REVIAN 102: The REVIAN System includes a Cap configured for portable use with rechargeable battery and adapter with active LEDs using modulated light therapy (MLT trademark). Daily 10-minute treatments are done in the home over the course of 26 weeks. Intervention adherence will be assessed via firmware in the Cap and monitored by the clinical sites.
|
Active REVIAN Cap 103
n=38 Participants
(1.67mW/cm2 of 425 + 1.67mW/cm2 of 625 nm and 660 nm)
REVIAN 103: The REVIAN System includes a Cap configured for portable use with rechargeable battery and adapter with active LEDs using modulated light therapy (MLT trademark). Daily 10-minute treatments are done in the home over the course of 26 weeks. Intervention adherence will be assessed via firmware in the Cap and monitored by the clinical sites.
|
Total
n=160 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
43.9 years
STANDARD_DEVIATION 12.06 • n=42 Participants
|
41 years
STANDARD_DEVIATION 12.3 • n=39 Participants
|
45.4 years
STANDARD_DEVIATION 9.71 • n=41 Participants
|
42.6 years
STANDARD_DEVIATION 10.41 • n=38 Participants
|
42.5 years
STANDARD_DEVIATION 12.2 • n=160 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=42 Participants
|
9 Participants
n=39 Participants
|
11 Participants
n=41 Participants
|
8 Participants
n=38 Participants
|
40 Participants
n=160 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=42 Participants
|
30 Participants
n=39 Participants
|
30 Participants
n=41 Participants
|
30 Participants
n=38 Participants
|
120 Participants
n=160 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=42 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=38 Participants
|
0 Participants
n=160 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=42 Participants
|
6 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
2 Participants
n=38 Participants
|
19 Participants
n=160 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=42 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=38 Participants
|
0 Participants
n=160 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=42 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=38 Participants
|
1 Participants
n=160 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=42 Participants
|
29 Participants
n=39 Participants
|
31 Participants
n=41 Participants
|
29 Participants
n=38 Participants
|
118 Participants
n=160 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=42 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=38 Participants
|
0 Participants
n=160 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=42 Participants
|
4 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
7 Participants
n=38 Participants
|
22 Participants
n=160 Participants
|
|
Region of Enrollment
Australia
|
42 Participants
n=42 Participants
|
39 Participants
n=39 Participants
|
41 Participants
n=41 Participants
|
38 Participants
n=38 Participants
|
160 Participants
n=160 Participants
|
|
Fitzpatrick Skin Type
Type I
|
1 Participants
n=42 Participants
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
3 Participants
n=38 Participants
|
5 Participants
n=160 Participants
|
|
Fitzpatrick Skin Type
Type II
|
15 Participants
n=42 Participants
|
13 Participants
n=39 Participants
|
15 Participants
n=41 Participants
|
13 Participants
n=38 Participants
|
56 Participants
n=160 Participants
|
|
Fitzpatrick Skin Type
Type III
|
14 Participants
n=42 Participants
|
14 Participants
n=39 Participants
|
17 Participants
n=41 Participants
|
13 Participants
n=38 Participants
|
58 Participants
n=160 Participants
|
|
Fitzpatrick Skin Type
Type IV
|
12 Participants
n=42 Participants
|
11 Participants
n=39 Participants
|
9 Participants
n=41 Participants
|
9 Participants
n=38 Participants
|
41 Participants
n=160 Participants
|
|
Hamilton-Norwood Hair Loss Scale
IIa
|
2 participants
n=30 Participants • Male participants were analyzed using this scale. Categories are not mutually exclusive. Note: The Norwood scale was used to classify one female subject. Female subject VCR-101, assigned to the Active REVIAN Cap 101 group, has result in Norwood-Hamilton Hair Loss Scale as 'IIa'. Therefore, the Active REVIAN Cap 101 group has a total of 31 (instead of 30) and the total baseline participants 121 (instead of 120).
|
3 participants
n=31 Participants • Male participants were analyzed using this scale. Categories are not mutually exclusive. Note: The Norwood scale was used to classify one female subject. Female subject VCR-101, assigned to the Active REVIAN Cap 101 group, has result in Norwood-Hamilton Hair Loss Scale as 'IIa'. Therefore, the Active REVIAN Cap 101 group has a total of 31 (instead of 30) and the total baseline participants 121 (instead of 120).
|
0 participants
n=30 Participants • Male participants were analyzed using this scale. Categories are not mutually exclusive. Note: The Norwood scale was used to classify one female subject. Female subject VCR-101, assigned to the Active REVIAN Cap 101 group, has result in Norwood-Hamilton Hair Loss Scale as 'IIa'. Therefore, the Active REVIAN Cap 101 group has a total of 31 (instead of 30) and the total baseline participants 121 (instead of 120).
|
3 participants
n=30 Participants • Male participants were analyzed using this scale. Categories are not mutually exclusive. Note: The Norwood scale was used to classify one female subject. Female subject VCR-101, assigned to the Active REVIAN Cap 101 group, has result in Norwood-Hamilton Hair Loss Scale as 'IIa'. Therefore, the Active REVIAN Cap 101 group has a total of 31 (instead of 30) and the total baseline participants 121 (instead of 120).
|
8 participants
n=121 Participants • Male participants were analyzed using this scale. Categories are not mutually exclusive. Note: The Norwood scale was used to classify one female subject. Female subject VCR-101, assigned to the Active REVIAN Cap 101 group, has result in Norwood-Hamilton Hair Loss Scale as 'IIa'. Therefore, the Active REVIAN Cap 101 group has a total of 31 (instead of 30) and the total baseline participants 121 (instead of 120).
|
|
Hamilton-Norwood Hair Loss Scale
III
|
3 participants
n=30 Participants • Male participants were analyzed using this scale. Categories are not mutually exclusive. Note: The Norwood scale was used to classify one female subject. Female subject VCR-101, assigned to the Active REVIAN Cap 101 group, has result in Norwood-Hamilton Hair Loss Scale as 'IIa'. Therefore, the Active REVIAN Cap 101 group has a total of 31 (instead of 30) and the total baseline participants 121 (instead of 120).
|
4 participants
n=31 Participants • Male participants were analyzed using this scale. Categories are not mutually exclusive. Note: The Norwood scale was used to classify one female subject. Female subject VCR-101, assigned to the Active REVIAN Cap 101 group, has result in Norwood-Hamilton Hair Loss Scale as 'IIa'. Therefore, the Active REVIAN Cap 101 group has a total of 31 (instead of 30) and the total baseline participants 121 (instead of 120).
|
2 participants
n=30 Participants • Male participants were analyzed using this scale. Categories are not mutually exclusive. Note: The Norwood scale was used to classify one female subject. Female subject VCR-101, assigned to the Active REVIAN Cap 101 group, has result in Norwood-Hamilton Hair Loss Scale as 'IIa'. Therefore, the Active REVIAN Cap 101 group has a total of 31 (instead of 30) and the total baseline participants 121 (instead of 120).
|
5 participants
n=30 Participants • Male participants were analyzed using this scale. Categories are not mutually exclusive. Note: The Norwood scale was used to classify one female subject. Female subject VCR-101, assigned to the Active REVIAN Cap 101 group, has result in Norwood-Hamilton Hair Loss Scale as 'IIa'. Therefore, the Active REVIAN Cap 101 group has a total of 31 (instead of 30) and the total baseline participants 121 (instead of 120).
|
14 participants
n=121 Participants • Male participants were analyzed using this scale. Categories are not mutually exclusive. Note: The Norwood scale was used to classify one female subject. Female subject VCR-101, assigned to the Active REVIAN Cap 101 group, has result in Norwood-Hamilton Hair Loss Scale as 'IIa'. Therefore, the Active REVIAN Cap 101 group has a total of 31 (instead of 30) and the total baseline participants 121 (instead of 120).
|
|
Hamilton-Norwood Hair Loss Scale
IIIa
|
1 participants
n=30 Participants • Male participants were analyzed using this scale. Categories are not mutually exclusive. Note: The Norwood scale was used to classify one female subject. Female subject VCR-101, assigned to the Active REVIAN Cap 101 group, has result in Norwood-Hamilton Hair Loss Scale as 'IIa'. Therefore, the Active REVIAN Cap 101 group has a total of 31 (instead of 30) and the total baseline participants 121 (instead of 120).
|
0 participants
n=31 Participants • Male participants were analyzed using this scale. Categories are not mutually exclusive. Note: The Norwood scale was used to classify one female subject. Female subject VCR-101, assigned to the Active REVIAN Cap 101 group, has result in Norwood-Hamilton Hair Loss Scale as 'IIa'. Therefore, the Active REVIAN Cap 101 group has a total of 31 (instead of 30) and the total baseline participants 121 (instead of 120).
|
3 participants
n=30 Participants • Male participants were analyzed using this scale. Categories are not mutually exclusive. Note: The Norwood scale was used to classify one female subject. Female subject VCR-101, assigned to the Active REVIAN Cap 101 group, has result in Norwood-Hamilton Hair Loss Scale as 'IIa'. Therefore, the Active REVIAN Cap 101 group has a total of 31 (instead of 30) and the total baseline participants 121 (instead of 120).
|
1 participants
n=30 Participants • Male participants were analyzed using this scale. Categories are not mutually exclusive. Note: The Norwood scale was used to classify one female subject. Female subject VCR-101, assigned to the Active REVIAN Cap 101 group, has result in Norwood-Hamilton Hair Loss Scale as 'IIa'. Therefore, the Active REVIAN Cap 101 group has a total of 31 (instead of 30) and the total baseline participants 121 (instead of 120).
|
5 participants
n=121 Participants • Male participants were analyzed using this scale. Categories are not mutually exclusive. Note: The Norwood scale was used to classify one female subject. Female subject VCR-101, assigned to the Active REVIAN Cap 101 group, has result in Norwood-Hamilton Hair Loss Scale as 'IIa'. Therefore, the Active REVIAN Cap 101 group has a total of 31 (instead of 30) and the total baseline participants 121 (instead of 120).
|
|
Hamilton-Norwood Hair Loss Scale
III vertex
|
12 participants
n=30 Participants • Male participants were analyzed using this scale. Categories are not mutually exclusive. Note: The Norwood scale was used to classify one female subject. Female subject VCR-101, assigned to the Active REVIAN Cap 101 group, has result in Norwood-Hamilton Hair Loss Scale as 'IIa'. Therefore, the Active REVIAN Cap 101 group has a total of 31 (instead of 30) and the total baseline participants 121 (instead of 120).
|
7 participants
n=31 Participants • Male participants were analyzed using this scale. Categories are not mutually exclusive. Note: The Norwood scale was used to classify one female subject. Female subject VCR-101, assigned to the Active REVIAN Cap 101 group, has result in Norwood-Hamilton Hair Loss Scale as 'IIa'. Therefore, the Active REVIAN Cap 101 group has a total of 31 (instead of 30) and the total baseline participants 121 (instead of 120).
|
9 participants
n=30 Participants • Male participants were analyzed using this scale. Categories are not mutually exclusive. Note: The Norwood scale was used to classify one female subject. Female subject VCR-101, assigned to the Active REVIAN Cap 101 group, has result in Norwood-Hamilton Hair Loss Scale as 'IIa'. Therefore, the Active REVIAN Cap 101 group has a total of 31 (instead of 30) and the total baseline participants 121 (instead of 120).
|
6 participants
n=30 Participants • Male participants were analyzed using this scale. Categories are not mutually exclusive. Note: The Norwood scale was used to classify one female subject. Female subject VCR-101, assigned to the Active REVIAN Cap 101 group, has result in Norwood-Hamilton Hair Loss Scale as 'IIa'. Therefore, the Active REVIAN Cap 101 group has a total of 31 (instead of 30) and the total baseline participants 121 (instead of 120).
|
34 participants
n=121 Participants • Male participants were analyzed using this scale. Categories are not mutually exclusive. Note: The Norwood scale was used to classify one female subject. Female subject VCR-101, assigned to the Active REVIAN Cap 101 group, has result in Norwood-Hamilton Hair Loss Scale as 'IIa'. Therefore, the Active REVIAN Cap 101 group has a total of 31 (instead of 30) and the total baseline participants 121 (instead of 120).
|
|
Hamilton-Norwood Hair Loss Scale
IV
|
5 participants
n=30 Participants • Male participants were analyzed using this scale. Categories are not mutually exclusive. Note: The Norwood scale was used to classify one female subject. Female subject VCR-101, assigned to the Active REVIAN Cap 101 group, has result in Norwood-Hamilton Hair Loss Scale as 'IIa'. Therefore, the Active REVIAN Cap 101 group has a total of 31 (instead of 30) and the total baseline participants 121 (instead of 120).
|
10 participants
n=31 Participants • Male participants were analyzed using this scale. Categories are not mutually exclusive. Note: The Norwood scale was used to classify one female subject. Female subject VCR-101, assigned to the Active REVIAN Cap 101 group, has result in Norwood-Hamilton Hair Loss Scale as 'IIa'. Therefore, the Active REVIAN Cap 101 group has a total of 31 (instead of 30) and the total baseline participants 121 (instead of 120).
|
10 participants
n=30 Participants • Male participants were analyzed using this scale. Categories are not mutually exclusive. Note: The Norwood scale was used to classify one female subject. Female subject VCR-101, assigned to the Active REVIAN Cap 101 group, has result in Norwood-Hamilton Hair Loss Scale as 'IIa'. Therefore, the Active REVIAN Cap 101 group has a total of 31 (instead of 30) and the total baseline participants 121 (instead of 120).
|
11 participants
n=30 Participants • Male participants were analyzed using this scale. Categories are not mutually exclusive. Note: The Norwood scale was used to classify one female subject. Female subject VCR-101, assigned to the Active REVIAN Cap 101 group, has result in Norwood-Hamilton Hair Loss Scale as 'IIa'. Therefore, the Active REVIAN Cap 101 group has a total of 31 (instead of 30) and the total baseline participants 121 (instead of 120).
|
36 participants
n=121 Participants • Male participants were analyzed using this scale. Categories are not mutually exclusive. Note: The Norwood scale was used to classify one female subject. Female subject VCR-101, assigned to the Active REVIAN Cap 101 group, has result in Norwood-Hamilton Hair Loss Scale as 'IIa'. Therefore, the Active REVIAN Cap 101 group has a total of 31 (instead of 30) and the total baseline participants 121 (instead of 120).
|
|
Hamilton-Norwood Hair Loss Scale
IVa
|
0 participants
n=30 Participants • Male participants were analyzed using this scale. Categories are not mutually exclusive. Note: The Norwood scale was used to classify one female subject. Female subject VCR-101, assigned to the Active REVIAN Cap 101 group, has result in Norwood-Hamilton Hair Loss Scale as 'IIa'. Therefore, the Active REVIAN Cap 101 group has a total of 31 (instead of 30) and the total baseline participants 121 (instead of 120).
|
0 participants
n=31 Participants • Male participants were analyzed using this scale. Categories are not mutually exclusive. Note: The Norwood scale was used to classify one female subject. Female subject VCR-101, assigned to the Active REVIAN Cap 101 group, has result in Norwood-Hamilton Hair Loss Scale as 'IIa'. Therefore, the Active REVIAN Cap 101 group has a total of 31 (instead of 30) and the total baseline participants 121 (instead of 120).
|
0 participants
n=30 Participants • Male participants were analyzed using this scale. Categories are not mutually exclusive. Note: The Norwood scale was used to classify one female subject. Female subject VCR-101, assigned to the Active REVIAN Cap 101 group, has result in Norwood-Hamilton Hair Loss Scale as 'IIa'. Therefore, the Active REVIAN Cap 101 group has a total of 31 (instead of 30) and the total baseline participants 121 (instead of 120).
|
0 participants
n=30 Participants • Male participants were analyzed using this scale. Categories are not mutually exclusive. Note: The Norwood scale was used to classify one female subject. Female subject VCR-101, assigned to the Active REVIAN Cap 101 group, has result in Norwood-Hamilton Hair Loss Scale as 'IIa'. Therefore, the Active REVIAN Cap 101 group has a total of 31 (instead of 30) and the total baseline participants 121 (instead of 120).
|
0 participants
n=121 Participants • Male participants were analyzed using this scale. Categories are not mutually exclusive. Note: The Norwood scale was used to classify one female subject. Female subject VCR-101, assigned to the Active REVIAN Cap 101 group, has result in Norwood-Hamilton Hair Loss Scale as 'IIa'. Therefore, the Active REVIAN Cap 101 group has a total of 31 (instead of 30) and the total baseline participants 121 (instead of 120).
|
|
Hamilton-Norwood Hair Loss Scale
V
|
7 participants
n=30 Participants • Male participants were analyzed using this scale. Categories are not mutually exclusive. Note: The Norwood scale was used to classify one female subject. Female subject VCR-101, assigned to the Active REVIAN Cap 101 group, has result in Norwood-Hamilton Hair Loss Scale as 'IIa'. Therefore, the Active REVIAN Cap 101 group has a total of 31 (instead of 30) and the total baseline participants 121 (instead of 120).
|
7 participants
n=31 Participants • Male participants were analyzed using this scale. Categories are not mutually exclusive. Note: The Norwood scale was used to classify one female subject. Female subject VCR-101, assigned to the Active REVIAN Cap 101 group, has result in Norwood-Hamilton Hair Loss Scale as 'IIa'. Therefore, the Active REVIAN Cap 101 group has a total of 31 (instead of 30) and the total baseline participants 121 (instead of 120).
|
6 participants
n=30 Participants • Male participants were analyzed using this scale. Categories are not mutually exclusive. Note: The Norwood scale was used to classify one female subject. Female subject VCR-101, assigned to the Active REVIAN Cap 101 group, has result in Norwood-Hamilton Hair Loss Scale as 'IIa'. Therefore, the Active REVIAN Cap 101 group has a total of 31 (instead of 30) and the total baseline participants 121 (instead of 120).
|
4 participants
n=30 Participants • Male participants were analyzed using this scale. Categories are not mutually exclusive. Note: The Norwood scale was used to classify one female subject. Female subject VCR-101, assigned to the Active REVIAN Cap 101 group, has result in Norwood-Hamilton Hair Loss Scale as 'IIa'. Therefore, the Active REVIAN Cap 101 group has a total of 31 (instead of 30) and the total baseline participants 121 (instead of 120).
|
24 participants
n=121 Participants • Male participants were analyzed using this scale. Categories are not mutually exclusive. Note: The Norwood scale was used to classify one female subject. Female subject VCR-101, assigned to the Active REVIAN Cap 101 group, has result in Norwood-Hamilton Hair Loss Scale as 'IIa'. Therefore, the Active REVIAN Cap 101 group has a total of 31 (instead of 30) and the total baseline participants 121 (instead of 120).
|
|
Ludwig-Savin Scale
I-1
|
2 participants
n=12 Participants • Female participants were analyzed using this scale. Note: Female subject VCR-101 in the Active REVIAN Cap 101 group was inadvertently assigned a classification from the Norwood-Hamilton Hair Loss Scale (assigned 'IIa') and not assigned a classification from the Ludwig-Savin Scale. Therefore, there are only a total 8 subjects in the Active REVIAN Cap 101 group (instead of 9) and a total of 39 subjects (instead of 40) reported in the table.
|
0 participants
n=8 Participants • Female participants were analyzed using this scale. Note: Female subject VCR-101 in the Active REVIAN Cap 101 group was inadvertently assigned a classification from the Norwood-Hamilton Hair Loss Scale (assigned 'IIa') and not assigned a classification from the Ludwig-Savin Scale. Therefore, there are only a total 8 subjects in the Active REVIAN Cap 101 group (instead of 9) and a total of 39 subjects (instead of 40) reported in the table.
|
0 participants
n=11 Participants • Female participants were analyzed using this scale. Note: Female subject VCR-101 in the Active REVIAN Cap 101 group was inadvertently assigned a classification from the Norwood-Hamilton Hair Loss Scale (assigned 'IIa') and not assigned a classification from the Ludwig-Savin Scale. Therefore, there are only a total 8 subjects in the Active REVIAN Cap 101 group (instead of 9) and a total of 39 subjects (instead of 40) reported in the table.
|
0 participants
n=8 Participants • Female participants were analyzed using this scale. Note: Female subject VCR-101 in the Active REVIAN Cap 101 group was inadvertently assigned a classification from the Norwood-Hamilton Hair Loss Scale (assigned 'IIa') and not assigned a classification from the Ludwig-Savin Scale. Therefore, there are only a total 8 subjects in the Active REVIAN Cap 101 group (instead of 9) and a total of 39 subjects (instead of 40) reported in the table.
|
2 participants
n=39 Participants • Female participants were analyzed using this scale. Note: Female subject VCR-101 in the Active REVIAN Cap 101 group was inadvertently assigned a classification from the Norwood-Hamilton Hair Loss Scale (assigned 'IIa') and not assigned a classification from the Ludwig-Savin Scale. Therefore, there are only a total 8 subjects in the Active REVIAN Cap 101 group (instead of 9) and a total of 39 subjects (instead of 40) reported in the table.
|
|
Ludwig-Savin Scale
I-2
|
1 participants
n=12 Participants • Female participants were analyzed using this scale. Note: Female subject VCR-101 in the Active REVIAN Cap 101 group was inadvertently assigned a classification from the Norwood-Hamilton Hair Loss Scale (assigned 'IIa') and not assigned a classification from the Ludwig-Savin Scale. Therefore, there are only a total 8 subjects in the Active REVIAN Cap 101 group (instead of 9) and a total of 39 subjects (instead of 40) reported in the table.
|
1 participants
n=8 Participants • Female participants were analyzed using this scale. Note: Female subject VCR-101 in the Active REVIAN Cap 101 group was inadvertently assigned a classification from the Norwood-Hamilton Hair Loss Scale (assigned 'IIa') and not assigned a classification from the Ludwig-Savin Scale. Therefore, there are only a total 8 subjects in the Active REVIAN Cap 101 group (instead of 9) and a total of 39 subjects (instead of 40) reported in the table.
|
2 participants
n=11 Participants • Female participants were analyzed using this scale. Note: Female subject VCR-101 in the Active REVIAN Cap 101 group was inadvertently assigned a classification from the Norwood-Hamilton Hair Loss Scale (assigned 'IIa') and not assigned a classification from the Ludwig-Savin Scale. Therefore, there are only a total 8 subjects in the Active REVIAN Cap 101 group (instead of 9) and a total of 39 subjects (instead of 40) reported in the table.
|
1 participants
n=8 Participants • Female participants were analyzed using this scale. Note: Female subject VCR-101 in the Active REVIAN Cap 101 group was inadvertently assigned a classification from the Norwood-Hamilton Hair Loss Scale (assigned 'IIa') and not assigned a classification from the Ludwig-Savin Scale. Therefore, there are only a total 8 subjects in the Active REVIAN Cap 101 group (instead of 9) and a total of 39 subjects (instead of 40) reported in the table.
|
5 participants
n=39 Participants • Female participants were analyzed using this scale. Note: Female subject VCR-101 in the Active REVIAN Cap 101 group was inadvertently assigned a classification from the Norwood-Hamilton Hair Loss Scale (assigned 'IIa') and not assigned a classification from the Ludwig-Savin Scale. Therefore, there are only a total 8 subjects in the Active REVIAN Cap 101 group (instead of 9) and a total of 39 subjects (instead of 40) reported in the table.
|
|
Ludwig-Savin Scale
I-3
|
1 participants
n=12 Participants • Female participants were analyzed using this scale. Note: Female subject VCR-101 in the Active REVIAN Cap 101 group was inadvertently assigned a classification from the Norwood-Hamilton Hair Loss Scale (assigned 'IIa') and not assigned a classification from the Ludwig-Savin Scale. Therefore, there are only a total 8 subjects in the Active REVIAN Cap 101 group (instead of 9) and a total of 39 subjects (instead of 40) reported in the table.
|
1 participants
n=8 Participants • Female participants were analyzed using this scale. Note: Female subject VCR-101 in the Active REVIAN Cap 101 group was inadvertently assigned a classification from the Norwood-Hamilton Hair Loss Scale (assigned 'IIa') and not assigned a classification from the Ludwig-Savin Scale. Therefore, there are only a total 8 subjects in the Active REVIAN Cap 101 group (instead of 9) and a total of 39 subjects (instead of 40) reported in the table.
|
2 participants
n=11 Participants • Female participants were analyzed using this scale. Note: Female subject VCR-101 in the Active REVIAN Cap 101 group was inadvertently assigned a classification from the Norwood-Hamilton Hair Loss Scale (assigned 'IIa') and not assigned a classification from the Ludwig-Savin Scale. Therefore, there are only a total 8 subjects in the Active REVIAN Cap 101 group (instead of 9) and a total of 39 subjects (instead of 40) reported in the table.
|
2 participants
n=8 Participants • Female participants were analyzed using this scale. Note: Female subject VCR-101 in the Active REVIAN Cap 101 group was inadvertently assigned a classification from the Norwood-Hamilton Hair Loss Scale (assigned 'IIa') and not assigned a classification from the Ludwig-Savin Scale. Therefore, there are only a total 8 subjects in the Active REVIAN Cap 101 group (instead of 9) and a total of 39 subjects (instead of 40) reported in the table.
|
6 participants
n=39 Participants • Female participants were analyzed using this scale. Note: Female subject VCR-101 in the Active REVIAN Cap 101 group was inadvertently assigned a classification from the Norwood-Hamilton Hair Loss Scale (assigned 'IIa') and not assigned a classification from the Ludwig-Savin Scale. Therefore, there are only a total 8 subjects in the Active REVIAN Cap 101 group (instead of 9) and a total of 39 subjects (instead of 40) reported in the table.
|
|
Ludwig-Savin Scale
I-4
|
2 participants
n=12 Participants • Female participants were analyzed using this scale. Note: Female subject VCR-101 in the Active REVIAN Cap 101 group was inadvertently assigned a classification from the Norwood-Hamilton Hair Loss Scale (assigned 'IIa') and not assigned a classification from the Ludwig-Savin Scale. Therefore, there are only a total 8 subjects in the Active REVIAN Cap 101 group (instead of 9) and a total of 39 subjects (instead of 40) reported in the table.
|
3 participants
n=8 Participants • Female participants were analyzed using this scale. Note: Female subject VCR-101 in the Active REVIAN Cap 101 group was inadvertently assigned a classification from the Norwood-Hamilton Hair Loss Scale (assigned 'IIa') and not assigned a classification from the Ludwig-Savin Scale. Therefore, there are only a total 8 subjects in the Active REVIAN Cap 101 group (instead of 9) and a total of 39 subjects (instead of 40) reported in the table.
|
2 participants
n=11 Participants • Female participants were analyzed using this scale. Note: Female subject VCR-101 in the Active REVIAN Cap 101 group was inadvertently assigned a classification from the Norwood-Hamilton Hair Loss Scale (assigned 'IIa') and not assigned a classification from the Ludwig-Savin Scale. Therefore, there are only a total 8 subjects in the Active REVIAN Cap 101 group (instead of 9) and a total of 39 subjects (instead of 40) reported in the table.
|
3 participants
n=8 Participants • Female participants were analyzed using this scale. Note: Female subject VCR-101 in the Active REVIAN Cap 101 group was inadvertently assigned a classification from the Norwood-Hamilton Hair Loss Scale (assigned 'IIa') and not assigned a classification from the Ludwig-Savin Scale. Therefore, there are only a total 8 subjects in the Active REVIAN Cap 101 group (instead of 9) and a total of 39 subjects (instead of 40) reported in the table.
|
10 participants
n=39 Participants • Female participants were analyzed using this scale. Note: Female subject VCR-101 in the Active REVIAN Cap 101 group was inadvertently assigned a classification from the Norwood-Hamilton Hair Loss Scale (assigned 'IIa') and not assigned a classification from the Ludwig-Savin Scale. Therefore, there are only a total 8 subjects in the Active REVIAN Cap 101 group (instead of 9) and a total of 39 subjects (instead of 40) reported in the table.
|
|
Ludwig-Savin Scale
II-1
|
3 participants
n=12 Participants • Female participants were analyzed using this scale. Note: Female subject VCR-101 in the Active REVIAN Cap 101 group was inadvertently assigned a classification from the Norwood-Hamilton Hair Loss Scale (assigned 'IIa') and not assigned a classification from the Ludwig-Savin Scale. Therefore, there are only a total 8 subjects in the Active REVIAN Cap 101 group (instead of 9) and a total of 39 subjects (instead of 40) reported in the table.
|
1 participants
n=8 Participants • Female participants were analyzed using this scale. Note: Female subject VCR-101 in the Active REVIAN Cap 101 group was inadvertently assigned a classification from the Norwood-Hamilton Hair Loss Scale (assigned 'IIa') and not assigned a classification from the Ludwig-Savin Scale. Therefore, there are only a total 8 subjects in the Active REVIAN Cap 101 group (instead of 9) and a total of 39 subjects (instead of 40) reported in the table.
|
1 participants
n=11 Participants • Female participants were analyzed using this scale. Note: Female subject VCR-101 in the Active REVIAN Cap 101 group was inadvertently assigned a classification from the Norwood-Hamilton Hair Loss Scale (assigned 'IIa') and not assigned a classification from the Ludwig-Savin Scale. Therefore, there are only a total 8 subjects in the Active REVIAN Cap 101 group (instead of 9) and a total of 39 subjects (instead of 40) reported in the table.
|
1 participants
n=8 Participants • Female participants were analyzed using this scale. Note: Female subject VCR-101 in the Active REVIAN Cap 101 group was inadvertently assigned a classification from the Norwood-Hamilton Hair Loss Scale (assigned 'IIa') and not assigned a classification from the Ludwig-Savin Scale. Therefore, there are only a total 8 subjects in the Active REVIAN Cap 101 group (instead of 9) and a total of 39 subjects (instead of 40) reported in the table.
|
6 participants
n=39 Participants • Female participants were analyzed using this scale. Note: Female subject VCR-101 in the Active REVIAN Cap 101 group was inadvertently assigned a classification from the Norwood-Hamilton Hair Loss Scale (assigned 'IIa') and not assigned a classification from the Ludwig-Savin Scale. Therefore, there are only a total 8 subjects in the Active REVIAN Cap 101 group (instead of 9) and a total of 39 subjects (instead of 40) reported in the table.
|
|
Ludwig-Savin Scale
II-2
|
3 participants
n=12 Participants • Female participants were analyzed using this scale. Note: Female subject VCR-101 in the Active REVIAN Cap 101 group was inadvertently assigned a classification from the Norwood-Hamilton Hair Loss Scale (assigned 'IIa') and not assigned a classification from the Ludwig-Savin Scale. Therefore, there are only a total 8 subjects in the Active REVIAN Cap 101 group (instead of 9) and a total of 39 subjects (instead of 40) reported in the table.
|
2 participants
n=8 Participants • Female participants were analyzed using this scale. Note: Female subject VCR-101 in the Active REVIAN Cap 101 group was inadvertently assigned a classification from the Norwood-Hamilton Hair Loss Scale (assigned 'IIa') and not assigned a classification from the Ludwig-Savin Scale. Therefore, there are only a total 8 subjects in the Active REVIAN Cap 101 group (instead of 9) and a total of 39 subjects (instead of 40) reported in the table.
|
4 participants
n=11 Participants • Female participants were analyzed using this scale. Note: Female subject VCR-101 in the Active REVIAN Cap 101 group was inadvertently assigned a classification from the Norwood-Hamilton Hair Loss Scale (assigned 'IIa') and not assigned a classification from the Ludwig-Savin Scale. Therefore, there are only a total 8 subjects in the Active REVIAN Cap 101 group (instead of 9) and a total of 39 subjects (instead of 40) reported in the table.
|
1 participants
n=8 Participants • Female participants were analyzed using this scale. Note: Female subject VCR-101 in the Active REVIAN Cap 101 group was inadvertently assigned a classification from the Norwood-Hamilton Hair Loss Scale (assigned 'IIa') and not assigned a classification from the Ludwig-Savin Scale. Therefore, there are only a total 8 subjects in the Active REVIAN Cap 101 group (instead of 9) and a total of 39 subjects (instead of 40) reported in the table.
|
10 participants
n=39 Participants • Female participants were analyzed using this scale. Note: Female subject VCR-101 in the Active REVIAN Cap 101 group was inadvertently assigned a classification from the Norwood-Hamilton Hair Loss Scale (assigned 'IIa') and not assigned a classification from the Ludwig-Savin Scale. Therefore, there are only a total 8 subjects in the Active REVIAN Cap 101 group (instead of 9) and a total of 39 subjects (instead of 40) reported in the table.
|
PRIMARY outcome
Timeframe: Primary efficacy endpoint is 16-weeks follow-up from the initial application at baselinePopulation: Per Protocol with at least 80% treatment compliance as measured by the Revian mobile app
The primary efficacy outcome of this study is mean change in hair count from baseline. Standardized Canfield macro-photographs will be taken to capture digital images at baseline and will be compared to images captured at various endpoints throughout the study. Multiple images will be taken at each endpoint and will be reviewed by independent blinded observers to conduct the hair count
Outcome measures
| Measure |
Non-Active REVIAN (Sham) Cap 100
n=18 Participants
Sham (Control) Group
REVIAN 100: The REVIAN System includes a Cap configured for portable use with rechargeable battery and adapter with active LEDs using modulated light therapy (MLT trademark). Daily 10-minute treatments are done in the home over the course of 26 weeks. Intervention adherence will be assessed via firmware in the Cap and monitored by the clinical sites.
REVIAN 100 contains LEDs that are not powered for light therapy
|
Active REVIAN Cap 101
n=18 Participants
(625 nm and 660 nm)
REVIAN 101: The REVIAN System includes a Cap configured for portable use with rechargeable battery and adapter with active LEDs using modulated light therapy (MLT trademark). Daily 10-minute treatments are done in the home over the course of 26 weeks. Intervention adherence will be assessed via firmware in the Cap and monitored by the clinical sites.
REVIAN 101 delivers 625 nm and 660 nm wavelengths of red light.
|
Active REVIAN Cap 102
n=16 Participants
(425 nm)
The REVIAN System includes a Cap configured for portable use with rechargeable battery and adapter with active LEDs using modulated light therapy (MLT trademark). Daily 10-minute treatments are done in the home over the course of 26 weeks. Intervention adherence will be assessed via firmware in the Cap and monitored by the clinical sites.
REVIAN 102 delivers 425 nm wavelength of blue light.
|
Active REVIAN Cap 103
n=17 Participants
(425 nm, 625 nm and 660 nm
The REVIAN System includes a Cap configured for portable use with rechargeable battery and adapter with active LEDs using modulated light therapy (MLT trademark). Daily 10-minute treatments are done in the home over the course of 26 weeks. Intervention adherence will be assessed via firmware in the Cap and monitored by the clinical sites.
REVIAN 103 delivers 425 nm wavelength of blue light and 625 nm and 660 nm wavelengths of red light.
|
|---|---|---|---|---|
|
Mean Change in Terminal Hair Count From Baseline to 16 Weeks
|
-15.53 Change in total hair counts
Standard Error 11.3
|
14.26 Change in total hair counts
Standard Error 11.3
|
18.94 Change in total hair counts
Standard Error 12.0
|
5.22 Change in total hair counts
Standard Error 11.6
|
Adverse Events
Non-Active REVIAN (Sham) Cap 100
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Active REVIAN Cap 101
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Active REVIAN Cap 102
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Active REVIAN Cap 103
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Non-Active REVIAN (Sham) Cap 100
n=42 participants at risk
Sham (Control) Group
REVIAN 100: The REVIAN System includes a Cap configured for portable use with rechargeable battery and adapter with active LEDs using modulated light therapy (MLT trademark). Daily 10-minute treatments are done in the home over the course of 26 weeks. Intervention adherence will be assessed via firmware in the Cap and monitored by the clinical sites.
REVIAN 100 contains LEDs that are not powered for light therapy
|
Active REVIAN Cap 101
n=39 participants at risk
(625 nm and 660 nm)
REVIAN 101: The REVIAN System includes a Cap configured for portable use with rechargeable battery and adapter with active LEDs using modulated light therapy (MLT trademark). Daily 10-minute treatments are done in the home over the course of 26 weeks. Intervention adherence will be assessed via firmware in the Cap and monitored by the clinical sites.
REVIAN 101 delivers 625 nm and 660 nm wavelengths of red light.
|
Active REVIAN Cap 102
n=41 participants at risk
(425 nm)
REVIAN 102: The REVIAN System includes a Cap configured for portable use with rechargeable battery and adapter with active LEDs using modulated light therapy (MLT trademark). Daily 10-minute treatments are done in the home over the course of 26 weeks. Intervention adherence will be assessed via firmware in the Cap and monitored by the clinical sites.
REVIAN 102 delivers 425 nm wavelength of blue light.
|
Active REVIAN Cap 103
n=38 participants at risk
(425 nm, 625 nm and 660 nm)
The REVIAN System includes a Cap configured for portable use with rechargeable battery and adapter with active LEDs using modulated light therapy (MLT trademark). Daily 10-minute treatments are done in the home over the course of 26 weeks. Intervention adherence will be assessed via firmware in the Cap and monitored by the clinical sites.
REVIAN 103 delivers 425 nm wavelength of blue light and 625 nm and 660 nm wavelengths of red light.
|
|---|---|---|---|---|
|
Surgical and medical procedures
Invertebral disc operation
|
2.4%
1/42 • Number of events 1 • 26 weeks
|
0.00%
0/39 • 26 weeks
|
0.00%
0/41 • 26 weeks
|
0.00%
0/38 • 26 weeks
|
|
Gastrointestinal disorders
esophageal achalasia
|
0.00%
0/42 • 26 weeks
|
0.00%
0/39 • 26 weeks
|
2.4%
1/41 • Number of events 1 • 26 weeks
|
0.00%
0/38 • 26 weeks
|
|
Gastrointestinal disorders
gastroenteritis
|
0.00%
0/42 • 26 weeks
|
0.00%
0/39 • 26 weeks
|
2.4%
1/41 • Number of events 1 • 26 weeks
|
0.00%
0/38 • 26 weeks
|
Other adverse events
| Measure |
Non-Active REVIAN (Sham) Cap 100
n=42 participants at risk
Sham (Control) Group
REVIAN 100: The REVIAN System includes a Cap configured for portable use with rechargeable battery and adapter with active LEDs using modulated light therapy (MLT trademark). Daily 10-minute treatments are done in the home over the course of 26 weeks. Intervention adherence will be assessed via firmware in the Cap and monitored by the clinical sites.
REVIAN 100 contains LEDs that are not powered for light therapy
|
Active REVIAN Cap 101
n=39 participants at risk
(625 nm and 660 nm)
REVIAN 101: The REVIAN System includes a Cap configured for portable use with rechargeable battery and adapter with active LEDs using modulated light therapy (MLT trademark). Daily 10-minute treatments are done in the home over the course of 26 weeks. Intervention adherence will be assessed via firmware in the Cap and monitored by the clinical sites.
REVIAN 101 delivers 625 nm and 660 nm wavelengths of red light.
|
Active REVIAN Cap 102
n=41 participants at risk
(425 nm)
REVIAN 102: The REVIAN System includes a Cap configured for portable use with rechargeable battery and adapter with active LEDs using modulated light therapy (MLT trademark). Daily 10-minute treatments are done in the home over the course of 26 weeks. Intervention adherence will be assessed via firmware in the Cap and monitored by the clinical sites.
REVIAN 102 delivers 425 nm wavelength of blue light.
|
Active REVIAN Cap 103
n=38 participants at risk
(425 nm, 625 nm and 660 nm)
The REVIAN System includes a Cap configured for portable use with rechargeable battery and adapter with active LEDs using modulated light therapy (MLT trademark). Daily 10-minute treatments are done in the home over the course of 26 weeks. Intervention adherence will be assessed via firmware in the Cap and monitored by the clinical sites.
REVIAN 103 delivers 425 nm wavelength of blue light and 625 nm and 660 nm wavelengths of red light.
|
|---|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
4.8%
2/42 • 26 weeks
|
7.7%
3/39 • 26 weeks
|
9.8%
4/41 • 26 weeks
|
10.5%
4/38 • 26 weeks
|
|
Infections and infestations
Nasopharyngitis
|
7.1%
3/42 • 26 weeks
|
2.6%
1/39 • 26 weeks
|
0.00%
0/41 • 26 weeks
|
0.00%
0/38 • 26 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
4.8%
2/42 • 26 weeks
|
5.1%
2/39 • 26 weeks
|
0.00%
0/41 • 26 weeks
|
2.6%
1/38 • 26 weeks
|
|
Nervous system disorders
Headache
|
7.1%
3/42 • 26 weeks
|
5.1%
2/39 • 26 weeks
|
7.3%
3/41 • 26 weeks
|
0.00%
0/38 • 26 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee General Corporate Non-disclosure Agreement
- Publication restrictions are in place
Restriction type: OTHER